Prevention of hypoglycemia by intermittent-scanning continuous glucose monitoring device combined with structured education in patients with type 1 diabetes mellitus: A randomized, crossover trial
Takashi Murata, Kiminori Hosoda, Kunihiro Nishimura, Yoshihiro Miyamoto, Naoki Sakane, Noriko Satoh‐Asahara, Masao Toyoda, Yushi Hirota, Munehide Matsuhisa, Akio Kuroda, Ken Kato, Ryuji Kouyama, Junnosuke Miura, Atsuhito Tone, Masato Kasahara, Shu Kasama, Shota Suzuki, Yukie Ito, Tomokazu Watanabe, Akiko Suganuma, Zhuo Shen, Hiroko Kobayashi, Satoshi Takagi, Sari Hoshina, Kanako Shimura, Yukiko Tsuchida, Moritsugu Kimura, Nobumichi Saito, Akira Shimada, Yoichi Oikawa, Atsushi Satomura, Akifumi Haisa, Satoshi Kawashima, Shu Meguro, Hiroshi Itoh, Yoshifumi Saisho, Junichiro Irie, Masami Tanaka, Masanori Mitsuishi, Yuya Nakajima, Jun Inaishi, Kenichiro Kinouchi, Shintaro Yamaguchi, Arata Itoh, Kazutoshi Sugiyama, Kazuma Yagi, Tami Tsuchiya, Noriko Kodani, Ikki Shimizu, Tetsuya Fukuda, Yoshiki Kusunoki, Tomoyuki Katsuno, Yuka Matoba, Yumi Hitaka, Kentaro Abe, Natsuko Tanaka, Ryoko Taniguchi, Toshihiko Nagao, Kazuyuki Hida, Izumi Iseda, Masaya Takeda, Yuichi Matsushita, Masafumi Tenta, Tsuyoshi Tanaka, Kunichi Kouyama, Michiru Fukunaga
Abstract
AIMS: We conducted a randomized, crossover trial to compare intermittent-scanning continuous glucose monitoring (isCGM) device with structured education (Intervention) to self-monitoring of blood glucose (SMBG) (Control) in the reduction of time below range. METHODS: This crossover trial involved 104 adults with type 1 diabetes mellitus (T1DM) using multiple daily injections. Participants were randomly allocated to either sequence Intervention/Control or sequence Control/Intervention. During the Intervention period which lasted 84 days, participants used the first-generation FreeStyle Libre (Abbott Diabetes Care, Alameda, CA, USA) and received structured education on how to prevent hypoglycemia based on the trend arrow and by frequent sensor scanning (≥10 times a day). Confirmatory SMBG was conducted before dosing insulin. The Control period lasted 84 days. The primary endpoint was the decrease in the time below range (TBR; <70 mg/dL). RESULTS: The time below range was significantly reduced in the Intervention arm compared to the Control arm (2.42 ± 1.68 h/day [10.1 %±7.0 %] vs 3.10 ± 2.28 h/day [12.9 %±9.5 %], P = 0.012). The ratio of high-risk participants with low blood glucose index >5 was significantly reduced (8.6 % vs 23.7 %, P < 0.001). CONCLUSIONS: The use of isCGM combined with structured education significantly reduced the time below range in patients with T1DM.